The present invention relates to a container for use in the sterilization of surgical or medical items such as surgical instruments, implants and prosthetic devices. The sterilization container of the present invention is particularly suitable for, though not necessarily limited to, use in flash sterilization procedures currently used in operating suites or emergency rooms for establishing sterile conditions for these instruments and devices (collectively referred to as "medical items").
There are a number of different processes for sterilizing medical items which are recognized in the industry as effective. Examples include steam sterilization, exposure to radiation or application of a gas such as ethylene oxide. By way of example, conventional steam (i.e., autoclave) sterilization is widely used in hospital central supply areas where the item is not intended to be put to immediate use. This procedure requires exposure to steam at 250.degree. F. for at least 15 minutes. So-called "flash" sterilization which is more commonly used in operating suites or emergency rooms, subjects the items to higher temperatures (e.g., 270.degree. F.) for a shorter time (three minutes or more) according to well-known and professionally accepted data relating sterilization to these parameters.
Of primary consideration in sterilizing items for storage in central supply for later use is the fact that some provision must be made for maintaining sterility. This may be accomplished through special apparatus such as re-usable, metal containers with valves or filters, or by wrapping conventional open trays with commercially available sterilization wrap which may then be strip-taped for signifying that the wrapped item has been processed and, perhaps, identifying when it was processed.
These rather elaborate provisions for maintaining sterility after it is established are not of concern in flash sterilization technique because the item will normally be used immediately. Of concern in flash sterilization, however, is the convenience and speed in the use of the apparatus, the safety of the procedures employed and the acceptance of the techniques by operating personnel.
The device perhaps most commonly used for flash sterilization is an open stainless steel tray having a perforated or metal mesh bottom. Although these trays are also suitable for complete wrapping with a sterilization wrap and storage in a central supply area, they are considered useful for flash sterilization because they provide greater line-of-sight steam penetration than trays with closeable tops and quickness and completeness of steam penetration are of primary concern in flash sterilization procedures.
There are a number of disadvantages associated with such conventional trays currently used to flash sterilize medical items. One of the more common disadvantages with the apparatus is that of weight. Metal trays, whether stainless steel or aluminum, are heavy. The added weight of instruments makes these trays even more difficult in handling and manuevering.
Another disadvantage of metal trays is that their temperature remains high following sterilization; and special precautionary procedures are sometimes required to handle them. For example, clamps or cushioned heat pads are sometimes used in handling metal trays immediately following steam sterilization. Further, there is a tendency for condensate to form on metal trays used in steam sterilization procedures. Special precautions to prevent accumulation of excess condensate, such as lining the bottom of the tray with towels are sometimes taken with conventional metal trays.
Another disadvantage of metal trays having perforated or mesh bottoms is that even stainless steel is subject to corrosive attack or oxidation in the extremely hostile environment of repeated exposure to steam.